kro 406

kro 406
SPL v2
SPL
SPL Set ID 2f10041a-8c88-09a5-e063-6294a90a07cc
Route
oral
Published
Effective Date 2013-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (100 mg)
Inactive Ingredients
titanium dioxide d&c red no. 33 polyethylene glycol 400 fd&c red no. 40 gelatin glycerin sorbitol water fd&c yellow no. 6

Identifiers & Packaging

Pill Appearance
Imprint: SCU2 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-09-01

Purpose

Stool Softener

Description

Docusate Sodium 100 mg


Medication Information

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• noticed a sudden change in bowel habits that lasts longer than 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

• you need to use a laxative longer than 1 week

If pregnant or breast-feeding, ask a health professional before use.

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool Softener

Directions

• do not exceed recommended dose

• adults and children 12 years of age and older: take 1-3

softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor

• children under 12: ask a doctor

Other Information

each softgel contains: sodium 7 mg. very low sodium

• store at 59°-77°F (15°-25°C)

• keep tightly closed

Inactive Ingredients

gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol. Contains less that 1% of D&C red #33, edible ink, FD&C red #40, FD&C yellow #6 (sunset yellow), titanium dioxide

Description

Docusate Sodium 100 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg


Structured Label Content

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• noticed a sudden change in bowel habits that lasts longer than 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.

• you need to use a laxative longer than 1 week

If pregnant or breast-feeding, ask a health professional before use.

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool Softener

Directions

• do not exceed recommended dose

• adults and children 12 years of age and older: take 1-3

softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor

• children under 12: ask a doctor

Other Information (Other information)

each softgel contains: sodium 7 mg. very low sodium

• store at 59°-77°F (15°-25°C)

• keep tightly closed

Inactive Ingredients (Inactive ingredients)

gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol. Contains less that 1% of D&C red #33, edible ink, FD&C red #40, FD&C yellow #6 (sunset yellow), titanium dioxide

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate Sodium 100 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)